Trial to Define the Safety and Tolerability of SGN-40, Rituximab, and Gemcitabine in Patients With DLBCL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00655837
Recruitment Status : Completed
First Posted : April 10, 2008
Last Update Posted : December 18, 2014
Genentech, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Brief Summary:
The purpose of this study is to determine safety and tolerability of combination therapy of SGN-40 with gemcitabine and rituximab for the treatment of lymphoma. This study is also intended to estimate how well your disease responds to this treatment.

Condition or disease Intervention/treatment Phase
Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Drug: SGN-40 Drug: rituximab Drug: gemcitabine Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib Study of SGN-40 in Combination With Rituximab and Gemcitabine for the Treatment of Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Study Start Date : April 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Arm Intervention/treatment
Experimental: 1 Drug: SGN-40
4-12mg/kg IV; Days 1, 4, 8, 15 and 22 of Cycle 1 and Days 1, 8 and 15 of Cycles 2-8.
Other Name: dacetuzumab

Drug: rituximab
375 mg/m2 IV injection; Days -2, 8, 15 and 22 of Cycle 1 and Day 1 of Cycles 2-8.
Other Name: Rituxan

Drug: gemcitabine
1000 mg/m2 IV Injection; Days 1 and 15 of all Cycles.
Other Name: Gemzar

Primary Outcome Measures :
  1. Determine the safety and adverse-event profile for combination therapy of SGN-40 with gemcitabine and rituximab. [ Time Frame: 10 months from registration of last patient ]

Secondary Outcome Measures :
  1. Estimate progression free survival, clinical response rates to treatment, and overall survival to determine efficacy. [ Time Frame: Follow-up every 6 weeks after end of treatment. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Have a histologic diagnosis of DLBCL, including transformed histology and follicular grade 3 disease.
  • Must have at least one site of biopsy-proven disease demonstrating both of the following: bidimensional measurable disease with the longest axis >= 1.5cm by radiographic imaging or positive FDG-PET scan at baseline.
  • Patients with DLBCL and who have either relapsed, refractory, or progressive disease following salvage therapy, OR relapsed, refractory, or progressive disease following initial therapy and be medically unfit to receive aggressive therapy.
  • Either fresh or archived tumor specimen must be available.

Exclusion Criteria:

  • Documented history within 6 months of registration of a cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms.
  • Patients who have received allogeneic stem cell transplant.
  • Patients with evidence of another invasive primary malignancy within the past three years other than non-melanoma skin cancer, cervical carcinoma in situ, in situ carcinoma of the breast, or fully resected prostate cancer with normal PSA within 8 weeks of registration.
  • Patients with any active systemic viral, bacterial, or fungal infection requiring intravenous anti-infectives within 4 weeks prior to first dose of study drug.
  • Patients with a history or clinical evidence of leptomeningeal or central nervous system (CNS) lymphoma.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00655837

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045-0510
United States, Illinois
Oncology Specialists
Park Ridge, Illinois, United States, 60068
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Seattle Genetics, Inc.
Genentech, Inc.
Study Director: Nancy Whiting, PharmD Seattle Genetics, Inc.

Publications of Results:
Responsible Party: Seattle Genetics, Inc. Identifier: NCT00655837     History of Changes
Other Study ID Numbers: SG040-0008
First Posted: April 10, 2008    Key Record Dates
Last Update Posted: December 18, 2014
Last Verified: December 2014

Keywords provided by Seattle Genetics, Inc.:
Antigens, CD40
Antibodies, Monoclonal
Combined Modality Therapy
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Hematologic Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents